Ilya Pharma’s ILP100 Phase I wound care therapy trial progresses swiftly to multiple dosing
The ILP technology is based on deploying chemokines,which until now have been regarded as too instable to be used as therapeutic agents. However, with ILP100, the lactic acid bacteria functions as small bioreactors in the wound, continuously producing the chemokine CXCL12 to the wound tissue. The founding team have described and published the full mechanism of action (Vågesjö et al., 2018, PNAS) which involves increasing the levels of CXCL12 in the wound so that “the body thinks that wound is much larger than it really is”. This results in more and more specified immune cells being recruited to the wound, and through e.g. secretion of TGFb, healing being accelerated. ILP100 represents both a novel drug delivery technology and a novel investigational new product (IMP) and is classified as an advanced therapy medicinal product by the EMA and as a low risk gene therapy candidate by the FDA.
The ongoing Phase I trial contains two parts, a single ascending dose part with three cohorts and the multi ascending dose part with three cohorts, where on cohort has already been enrolled. In total 36 healthy volunteers are included. The study is being conducted in Uppsala, Sweden at the Phase I unit at Uppsala University Hospital. The design and data points are based on the previous scientific findings and rationale and, in addition to the safety assessments, the study includes techniques such as non-invasive 3D imaging, monitoring of the microcirculation during the wound healing and investigations of the wound microbiome. In total >600 images of different kinds are acquired per subject allowing for very quantitative and analyses during the healing and scaring processes. The extensive analytical part and the investment in data is in line with the strategy of Ilya Pharma for the continued clinical development.
“We are pleased to have made such rapid progress since this is one of the first clinical trials to be conducted using genetically modified bacteria expressing a human protein. As such the protocol in the trial is really science-driven and the trial is unique,” says Evelina Vågesjö, Ilya Pharma’s CEO. “
“ILP100 has the potential to revolutionise/transform wound care. With my longstanding interest in the sector, I have watched Ilya Pharma’s progress with great interest and am now delighted to join the team and help accelerate successful clinical development,” says new advisor David Fairlamb.
Link to video update: https://vimeo.com/397266827
For more information please contact
Evelina Vågesjö, CEO
Tel: +46 (0) 70 636 64 94